Regulatory Affairs

Preparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations and other supporting docs. Required Candidate profileCandidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory...

ResponsibilitiesAs a regulatory affairs officer:ensure that a company's products comply with the regulations of the regions where they want to distribute themkeep up to date with national and international legislation, guidelines and customer practicesrespond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.collect, collate...

Hiring for a MNC company which is into chemical.Intrested can share cv on- Key Responsibilities:Regulatory Affairs & Product SafetyDevelop new SDS in coordination with external consultants, ensuring accurate information gathering, review, corrections, and customization.Handle customer queries related to SDS regulations and update SDS as required.Periodically...

Company Name: Exemed PharmaceuticalsDesignation - Drug Regulatory Affairs -Officer/Sr OfficerLocation - Vadodara ( Corporate Office)Market: DomesticPrimary Job DescriptionsHaving knowledge of SUGAM portal and CDSCO websiteSubmission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC.Application of CT-05 / CT- 04Application...

Job TitleSenior Executive /Manager 2 – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG11A/G11BLocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own...

Internship in Quality Control (QC)/Quality Assurance (QA)/Production/Regulatory Affairs in Pharmaceutical CompanyM.Sc./B.Sc/ M.Pharm/B.Pharm

*Key Responsibilities:Analytical Method Development & Validation*Develop and validate robust HPLC methods for characterization and quantification of biological products (e.g., monoclonal antibodies, recombinant proteins).Perform method optimization, robustness studies, and transfer protocols as per ICH guidelines.*Routine & Stability Testing*Conduct analysis...

Job TitleExecutive- Regulatory & Business ContinuityBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you...

Job TitleExecutive – Regulatory and Business ContinuityBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As...

Job TitleManager – Regulatory & Business ContinuityBusiness UnitR&D1 Regulatory AffairsJob GradeG11ALocationBarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you...